Robotically and manually operable uterine manipulators

ABSTRACT

A uterine manipulator includes a housing configured to be coupled to an instrument drive unit of a robotic system, a shaft extending distally from the housing, a tip hub pivotably coupled to a distal end portion of the shaft, an articulation disposed within the housing, and a handle operably coupled to either the housing or the shaft. The articulation assembly is configured to pivot the tip hub relative to the shaft and includes a drive cable operably coupled to the tip hub. The articulation assembly is actuatable manually by a user and robotically by the robotic system to pivot the tip hub relative to the shaft. The handle is configured to be manually gripped by a user for manual use of the uterine manipulator.

CROSS REFERENCE TO RELATED APPLICATION

The present application claims the benefit of and priority to U.S.Provisional Application Ser. No. 62/987,393, filed on Mar. 10, 2020, theentire disclosure of which is incorporated by reference herein.

FIELD

The present disclosure is generally related to surgical instruments.More specifically, the present disclosure relates to a surgicalinstrument, such as, for example, a uterine manipulator that is bothmanually operable by a user and robotically operable by a roboticsurgical system.

BACKGROUND

Uterine manipulators are medical instruments used for manipulating(e.g., moving or repositioning) a patient's uterus during medicalprocedures. Such procedures include laparoscopic gynecologic surgery,e.g., total laparoscopic hysterectomy (TLH) surgery. Uterinemanipulators typically include a proximal portion that remains externalto the patient's body during use and a distal portion that is insertedinto the patient's body. The proximal portion typically provides formanipulation of the instrument during use. The distal portion oftenincludes a tip sized to be inserted into and/or engage a uterus. Thedistal portion of the instrument is advanced through the vaginal cavityand cervix and into the uterus. With the distal portion inserted withina uterus, the uterus can be manipulated through user controlledmovements of the proximal portion. Following completion of a procedure,the instrument may be removed from the patient's body via the vaginalcavity.

SUMMARY

In one aspect of the present disclosure, a uterine manipulator isprovided and includes a housing configured to be coupled to aninstrument drive unit of a robotic system, a shaft extending distallyfrom the housing, a tip hub pivotably coupled to a distal end portion ofthe shaft, an articulation assembly disposed within the housing, and ahandle operably coupled to either the housing or the shaft. Thearticulation assembly is configured to pivot the tip hub relative to theshaft and includes a drive cable operably coupled to the tip hub. Thearticulation assembly is actuatable manually by a user and roboticallyby the robotic system to pivot the tip hub relative to the shaft. Thehandle is configured to be manually gripped by a user for manual use ofthe uterine manipulator.

In aspects, the articulation assembly includes a first driven memberrotationally supported in the housing and having a proximal end portionconfigured to be operably coupled to a first drive member of theinstrument drive unit and a first nut threadedly coupled to the firstdriven member such that the first nut translates along the first drivenmember upon rotation of the first driven member. A proximal end portionof the drive cable is operably coupled to the first nut and a distal endportion of the drive cable is operably coupled to the tip hub such thatthe drive cable longitudinally translates with the first nut andrelative to the first driven member in response to a rotation of thefirst driven member to articulate the tip hub relative to the shaft.

In aspects, the articulation assembly includes a second driven memberrotationally supported in the housing and having a proximal end portionconfigured to be operably coupled to a second drive member of theinstrument drive unit, a second nut threadedly coupled to the seconddriven member such that the second nut translates along the seconddriven member upon rotation of the second driven member, and a seconddrive cable coupled to the second nut. The second drive cable has aproximal end portion operably coupled to the second nut and a distal endportion coupled to the tip hub. The distal end portion of the drivecable is coupled to a first side of the tip hub and the distal endportion of the second drive cable is coupled to a second side of the tiphub.

In aspects, the uterine manipulator includes a rotatable collar operablycoupled to a distal end portion of the first driven member such that arotation of the collar rotates the first driven member. The collar mayhave a plurality of gear teeth extending from an inner peripherythereof, and the distal end portion of the first driven member has agear in meshing engagement with the plurality of gear teeth of thecollar.

In aspects, the first driven member is parallel with and offset from alongitudinal axis defined by the shaft.

In aspects, the handle extends outward from a proximal portion of thehousing and is permanently coupled to the housing.

In aspects, the handle is removably couplable to a proximal portion ofthe housing and includes a coupling member for releasably coupling thehandle to the housing and a window opening defined therethrough forpermitting the articulation assembly to couple to the instrument driveunit of the robotic system when the handle is coupled to the housing.

In aspects, the handle is operably coupled to the housing via a hinge asis movable between an unfolded configuration, where the handle extendssubstantially perpendicular relative to a surface of the housing, and afolded configuration, where the handle extends substantially parallelalong the surface of the housing. The housing may define a recessconfigured to receive the handle in the folded configuration.

In aspects, the shaft is detachable from the housing and the handle isoperably coupled to the shaft.

In aspects, a distal portion of the shaft is curved. Additionally, oralternatively, the shaft may define an internal lumen extending along alength of the shaft.

In another aspect of the disclosure, a uterine manipulator is providedand includes a housing configured to be coupled to an instrument driveunit of a robotic system, a shaft extending distally from the housing, atip hub pivotably coupled to a distal end portion of the shaft, anarticulation assembly disposed within the housing, and a handlepivotably coupled to the housing. The articulation assembly isconfigured to pivot the tip hub relative to the shaft and includes adrive cable operably coupled to the tip hub. The articulation assemblyis actuatable manually by a user and robotically by the robotic systemto pivot the tip hub relative to the shaft. The handle is pivotablycoupled to the housing via a hinge and is movable between an unfoldedconfiguration, where the handle extends substantially perpendicularrelative to a surface of the housing, and a folded configuration, wherethe handle extends substantially parallel along the surface of thehousing. The handle is configured to be manually gripped by a user formanual use of the uterine manipulator.

In aspects, the uterine manipulator includes a rotatable collar operablycoupled to the articulation assembly and configured to be manuallyrotated to pivot the tip hub relative to the shaft.

In aspects, the housing defines a recess and the handle is configured tobe positioned within the recess when in the folded configuration.

In aspects, the articulation assembly includes a first driven memberrotationally supported in the housing and having a proximal end portionconfigured to be operably coupled to a first drive member of theinstrument drive unit and a first nut threadedly coupled to the firstdriven member such that the first nut translates along the first drivenmember upon rotation of the first driven member. A proximal end portionof the drive cable is operably coupled to the first nut and a distal endportion of the drive cable is operably coupled to the tip hub such thatthe drive cable longitudinally translates with the first nut andrelative to the first driven member in response to a rotation of thefirst driven member to articulate the tip hub relative to the shaft.

In aspects, the articulation assembly includes a second driven memberrotationally supported in the housing and having a proximal end portionconfigured to be operably coupled to a second drive member of theinstrument drive unit, a second nut threadedly coupled to the seconddriven member such that the second nut translates along the seconddriven member upon rotation of the second driven member, and a seconddrive cable coupled to the second nut. The second drive cable has aproximal end portion operably coupled to the second nut and a distal endportion coupled to the tip hub. The distal end portion of the drivecable is coupled to a first side of the tip hub and the distal endportion of the second drive cable is coupled to a second side of the tiphub.

In yet another aspect of the disclosure, a uterine manipulator isprovided and includes a housing configured to be coupled to aninstrument drive unit of a robotic system, a shaft extending distallyfrom the housing, a tip hub pivotably coupled to a distal end portion ofthe shaft, an articulation assembly disposed within the housing, and ahandle removably coupled to the housing. The articulation assembly isconfigured to pivot the tip hub relative to the shaft and includes adrive cable operably coupled to the tip hub. The articulation assemblyis actuatable manually by a user and robotically by the robotic systemto pivot the tip hub relative to the shaft. The handle removably coupledto the housing via a coupling member and is configured to be manuallygripped by a user for manual use of the uterine manipulator.

In aspects, the uterine manipulator includes a rotatable collar operablycoupled to the articulation assembly and configured to be manuallyrotated to pivot the tip hub relative to the shaft.

In aspects, the handle defines a window opening for permitting thearticulation assembly to couple to the instrument drive unit of therobotic system when the handle is coupled to the housing.

As used herein, the term “distal” refers to that portion of thedescribed component which is farthest from the user, while the term“proximal” refers to that portion of the described component which isclosest to the user.

As used herein, the terms “parallel” and “perpendicular” are understoodto include relative configurations that are substantially parallel orperpendicular up to about + or −10 degrees from true parallel orperpendicular. Likewise, the terms “about” “substantially” and similarterms account for variation of up to about + or −10 percent.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosureand, together with a general description of the disclosure given above,and the detailed description of the embodiment(s) given below, serve toexplain the principles of the disclosure, wherein:

FIG. 1A is a side, front, perspective view illustrating a uterinemanipulator in accordance with the present disclosure;

FIG. 1B is a side, rear, perspective view illustrating the uterinemanipulator of FIG. 1A;

FIG. 2A is a front, side, perspective view illustrating another uterinemanipulator in accordance with the present disclosure;

FIG. 2B is a rear, side, perspective view illustrating the uterinemanipulator of FIG. 2A;

FIG. 3A is a front, side, perspective view illustrating another uterinemanipulator in accordance with the present disclosure disposed in afirst condition;

FIG. 3B is a rear, side, perspective view illustrating the uterinemanipulator of FIG. 3A disposed in a second condition;

FIG. 4A is a front, side, perspective view illustrating another uterinemanipulator in accordance with the present disclosure;

FIG. 4B is a rear, side, perspective view illustrating the uterinemanipulator of FIG. 4A;

FIG. 5 is a schematic illustration of a robotic surgical systemincluding a robotic surgical assembly in accordance with the presentdisclosure;

FIG. 6 is a perspective view illustrating a surgical robotic arm, aninstrument drive unit, and a uterine manipulator usable with the roboticsurgical assembly of FIG. 5 ;

FIG. 7 is a cutaway view illustrating components of an examplearticulation assembly of the uterine manipulator of FIG. 6 ;

FIG. 8 is a longitudinal cross-sectional view illustrating components ofthe articulation assembly of FIG. 7 ;

FIG. 9 is a side, perspective view of a distal portion of the uterinemanipulator of FIG. 6 ; and

FIG. 10 is a side perspective view, with parts removed, of the distalportion of the uterine manipulator of FIG. 6 .

DETAILED DESCRIPTION

Embodiments of the present disclosure will now be described in detailwith reference to the drawings, in which like reference numeralsdesignate identical or corresponding elements in each of the severalviews. In the following description, well-known functions orconstructions are not described in detail to avoid obscuring the presentdisclosure in unnecessary detail.

The present disclosure provides surgical instruments, e.g., uterinemanipulators, configured to facilitate transcervical evaluation.Although the aspects and features of the present disclosure are detailedbelow with respect to uterine manipulators, it is contemplated that theaspects and features of the present disclosure may likewise be utilizedwith any other suitable surgical instruments. Further, although theuterine manipulators of the present disclosure are detailed hereinbelowfor the purpose of facilitating transcervical evaluation, the uterinemanipulators of the present disclosure are also configured to facilitateperformance of other surgical tasks typically accomplished at least inpart using uterine manipulators, e.g., colpotomy procedures and/or othertasks associated with a hysterectomies; diagnostic procedures; tuballigations; treatment of endometriosis; removal of adhesions, fibroids,or cysts; etc.

FIGS. 1A-1B, FIGS. 2A-2B, FIGS. 3A-3B, and FIGS. 4A-4B illustrateuterine manipulators 100, 200, 300, and 400, respectively, which arecollectively referred to herein as the uterine manipulator 10 (FIGS.5-10 ). The uterine manipulator 10 is both robotically operable by arobotic surgical system 1 and manually operable by a user. Morespecifically, as described in greater detail below, the uterinemanipulator 10 includes components for manually operating andmanipulating the uterine manipulator 10 and components for coupling theuterine manipulator to a robotic surgical system 1 for roboticallyoperating and manipulating the uterine manipulator 10 and componentsthereof. The uterine manipulator 10 generally includes a housing 36, anarticulation assembly 38 (FIGS. 7-8 ) disposed within the housing 36, ashaft 40 extending distally from the housing 36, a tip hub 42 pivotablycoupled to a distal end portion 44 of the shaft 40, a tip member 34attached to the tip hub 42, and a cervical cup 46 positionable about theshaft 40. The articulation assembly 38 controls components of theuterine manipulator 10, for example the pivoting of tip hub 42, ismanually operable, for example via a user-controlled rotatable collar58, and robotically operable when the uterine manipulator 10 is coupledto a robotic surgical system 1. The shaft 40 may be straight or curvedat portions along its length.

With reference to FIGS. 1A-1B, uterine manipulator 100 includes a handle110 extending outwardly from a surface of the housing 36. The handle 110of uterine manipulator 100 may be fixedly coupled to the housing 36, ormay be formed as a single unitary component with the housing 36. Thehandle 110 is configured to be manually gripped by a user formanipulating the entire uterine manipulator 100 or only select portionsthereof (e.g., the tip hub 42). The handle 110 may extendperpendicularly relative to a longitudinal axis defined by the handle110 or at an angle relative thereto, e.g., between about 45 degrees and90 degrees. The handle 110 is positioned so as to not interfere with therobotic interface controls accessible from housing 36.

With reference to FIGS. 2A-2B, uterine manipulator 200 includes aremovable handle 210 configured to couple to at least one of the housing36 or the shaft 40. The handle 210 of uterine manipulator 200 is aseparate component from the housing 36 and is configured to be securedto the housing 36, or another portion of the uterine manipulator 200,via a coupling member 212. The handle 210 is configured to be manuallygripped by a user for manipulating the uterine manipulator 200 when thehandle 210 is coupled to the housing 36.

Coupling member 212 may be a snap-fit engagement mechanism for removablysecuring the handle 210 to the housing 36 or another portion of theuterine manipulator 200, such as the shaft 40. For example, couplingmember 212 may be a protrusion extending from a surface of the handle210 which is configured to snap-fit to a recess defined on an outersurface of the housing 36, though other engagement configurations arecontemplated for releasably securing the handle 210 to the housing 36.

The handle 210 may be removably secured to a proximal portion of thehousing 36. To prevent the handle 210 from obstructing an interfaceregion 37 where the uterine manipulator 200 couples to a roboticsurgical system 1, the handle 210 may define a window opening 214 whichserves to provide access to (or otherwise not obstruct) the roboticinterface controls, when such interface controls are located on aproximal end of the housing 36.

With reference to FIGS. 3A-3B, uterine manipulator 300 includes ahousing 36 having a foldable handle 310 configured to pivot relative tothe housing 36. The handle 310 of uterine manipulator 300 is coupled tothe housing 36, or another portion of the uterine manipulator 300, via ahinge 315 and is configured to transition between a folded configurationand an extended, unfolded configuration. The handle 310 is configured tobe manually gripped by a user for manipulating the uterine manipulator300 when the handle 310 is in the extended, unfolded configuration.

The hinge 315 may be a lockable hinge that enables a user to releasablylock the handle 310 in the folded and/or unfolded configurations. In theextended, unfolded configuration, the handle 310 extends substantiallyperpendicular relative to a longitudinal axis of the housing 36,outwardly from a surface of the housing 36, or at another suitable anglerelative thereto, e.g., between about 45 degrees and 90 degrees. In thefolded configuration, the handle 310 rests flat against a surface (forexample, a top surface) of the housing 36. The housing 36 may include arecess 336 configured to receive the handle 310 therein when the handle310 is in the folded configuration. The recess 336 may be defined alongan outer surface of the housing 36 and may be shaped and dimensioned tocorrespond in shape and size of the handle 310 so that the handle 310does not protrude fully, or partially, from the housing 36 when thehandle 310 is in the folded configuration.

With reference to FIGS. 4A-4B, uterine manipulator 400 includes aproximal portion 401 separable from a distal portion 402. The proximalportion 401 of the uterine manipulator 400 includes a housing 36 havingan articulation assembly 38 (FIGS. 7-8 ) disposed within the housing 36and a shaft 440 a extending distally from the housing 36. The distalportion 402 of the uterine manipulator 400 includes a shaft 440 bconfigured to couple to the shaft 440 a of the proximal portion 401 whenthe uterine manipulator 400 is used with a robotic surgical system 1.The shaft 440 b of the distal portion 402 also includes a handle 410extending therefrom for manual operation by a user when the uterinemanipulator 400 is manually operated and/or not coupled to a roboticsurgical system 1. The distal portion 402 of the uterine manipulator 400also includes a tip hub 42 pivotably coupled to a distal end portion 44of the shaft 440 b, a tip member 34 attached to the tip hub 42, and acervical cup 46 positionable about the shaft 440 b.

The distal portion 402 includes a coupling mechanism 402 a which isconfigured to secure to a corresponding coupling mechanism 401 a of theproximal portion 401. Coupling mechanisms 401 a, 402 a may be anysuitable structure for releasably securing the distal portion 402 to theproximal portion 401 of uterine manipulator 400. Additionally, couplingmechanisms 401 a, 402 a may include means for coupling any drivemembers, cabling, or fluid lumens that extend from the proximal portion401 to the distal portion 402.

Any of the above-described handles 110, 210, 310, 410 of uterinemanipulators 100, 200, 300, 400 may be operably coupled to thearticulation assembly 38, or otherwise coupled to the tip hub 42 (e.g.,via an independent drive rod) to articulate (e.g., pivot) the tip hub 42relative to the shaft 40. For example, an actuation linkage (e.g., acable, rod, or other suitable link) may extend through shaft 40 andoperably couples handle 110, 210, 310, 410 with tip hub 42 to enablepivoting of tip hub 42 relative to shaft 40 in response to pivoting ofhandle 110, 210, 310, 410 relative to shaft 40 and/or housing 36 (seeFIGS. 1A-4B). Other suitable configurations for pivoting tip hub 42relative to shaft 40 in response to manipulation of handle 110, 210,310, 410 (or a portion thereof; FIGS. 1A-4B) are also contemplated suchas, for example, other mechanical configurations, motor-drivenconfigurations, etc. Further, gearing or other suitable mechanisms maybe provided to amplify or attenuate the pivoting of tip hub 42 inresponse to manipulation of handle 110, 210, 310, 410 (see FIGS. 1A-4B).Handle 110, 210, 310, 410 (see FIGS. 1A-4B) may be pivotable in eitherdirection from an at-rest position relative to shaft 40, e.g., tothereby enable pivoting of tip hub 42 in either direction relative toshaft 40 from its at-rest position. Additionally, or alternatively, eachof uterine manipulators 100, 200, 300, 400 (see FIGS. 1A-4B) may includea manually operable rotatable collar 58 (described below) coupled to thearticulation assembly 38 to manually operate articulation (e.g.,pivoting) of the tip hub 42 relative to the shaft 40.

Referring to FIGS. 5 and 6 , a surgical system, such as, for example, arobotic surgical system 1, generally includes a plurality of surgicalrobotic arms 2, 3 having an instrument drive unit 20 removably attachedthereto; a control device 4; and an operating console 5 coupled to thecontrol device 4. A uterine manipulator 10 is removably attached theinstrument drive unit 20. As noted above, uterine manipulator 10 may beany of uterine manipulators 100, 200, 300, 400 described above (seeFIGS. 1A-4B). The uterine manipulator 10 is configured to be manuallyoperated by a user, to be operably coupled to the instrument drive unit20 for operation by the robotic surgical system 1, or both. Thus, theuterine manipulator 10, whether being operated manually or via a roboticsurgical system 1, may be inserted into a vaginal cavity for use infemale pelvic surgical procedures, such as a hysterectomy.

With continued reference to FIG. 5 , the operating console 5 includes adisplay device 6, which is set up in particular to displaythree-dimensional images, and manual input devices 7, 8, by means ofwhich a person (not shown), for example a surgeon, is able totelemanipulate the robotic arms 2, 3 in a first operating mode, as knownin principle to a person skilled in the art. Each of the robotic arms 2,3 may include a plurality of members, which are connected throughjoints. The robotic arms 2, 3 may be driven by electric drives (notshown) that are connected to the control device 4. The control device 4(e.g., a computer) is set up to activate the drives, in particular bymeans of a computer program, in such a way that the robotic arms 2, 3,their instrument drive units 20, and thus the uterine manipulators 10execute a desired movement according to a movement defined by means ofthe manual input devices 7, 8. The control device 4 may also be set upin such a way that it regulates the movement of the robotic arms 2, 3and/or of the drives.

The robotic surgical system 1 is configured for use on a patient “P”lying on a surgical table “ST” to be treated in a minimally invasivemanner by means of a surgical instrument, e.g., the uterine manipulator10. The robotic surgical system 1 may also include more than two roboticarms 2, 3, the additional robotic arms likewise being connected to thecontrol device 4 and being telemanipulatable by means of the operatingconsole 5. A surgical instrument, for example, the uterine manipulator10, may also be attached to the additional robotic arm.

The control device 4 may control a plurality of motors (Motor 1 . . . n)with each motor configured to drive a relative rotation of drivenmembers of the uterine manipulator 10 to effect operation and/ormovement of components of the uterine manipulator 10. It is contemplatedthat the control device 4 coordinates the activation of the variousmotors (Motor 1 . . . n) to coordinate a clockwise or counter-clockwiserotation of drive members of the instrument drive unit 20 in order tocoordinate an operation and/or movement of a respective driven member ofthe uterine manipulator 10.

With specific reference to FIG. 6 , the robotic surgical system 1includes a surgical robotic assembly 1 a, which includes the robotic arm2, the instrument drive unit 20 configured to be coupled to the roboticarm 2, and the uterine manipulator 10 configured to be coupled to theinstrument drive unit 20. The instrument drive unit 20 is configured forpowering the uterine manipulator 10 and to transfer power and actuationforces from its motors 22, 24 to driven members 30, 32 (FIG. 7 ) of theuterine manipulator 10 to ultimately drive movement of components of theuterine manipulator 10, for example, an articulation of a tip member 34of the uterine manipulator 10. The instrument drive unit 20 includesfirst and second drive members 26, 28 drivingly coupled to a respectivemotor 22, 24, such that the drive members 26, 28 are independentlyrotatable with respect to one another.

With reference to FIGS. 7-10 , the articulation assembly 38 is partiallydisposed within the housing 36 and includes first and second drivenmembers 30, 32 supported in the housing 36, first and second nuts 48, 50operably coupled to the respective first and second driven members 30,32, and first and second cables 52, 54 coupled to the respective firstand second nuts 48, 50. The first and second driven members 30, 32 maybe configured as lead screws having an external threading 53 disposedalong their length. Each of the first and second driven members 30, 32are parallel with, and offset from, a longitudinal axis defined by theshaft 40 and has a proximal end portion 30 a, 32 a, and a distal endportion 30 b, 32 b. The proximal end portion 30 a, 32 a of each of thedriven members 30, 32 has an input coupler 56, 57 (e.g., crossedprotrusion) configured to be non-rotatably coupled to a correspondingoutput coupler of the respective first and second drive members 26, 28(FIG. 6 ) of the instrument drive unit 20. As such, when the instrumentdrive unit 20 is operably coupled to the housing 36 of the uterinemanipulator 10, an actuation of the first and second motors 22, 24 ofthe instrument drive unit 20 drives a rotation of the first and seconddriven members 30, 32 of the articulation assembly 38.

The uterine manipulator 10 may include a manually-rotatable collar 58rotatably coupled to a distal end portion 60 of the housing 36 anddisposed about the shaft 40. The collar 58 has an outer peripheralsurface 62 defining a plurality of surface features 64 configured toassist a clinician in grasping the collar 58. An inner periphery 66 ofthe collar 58 defines a plurality of gear teeth 68 disposed in acircular array around the shaft 40. The distal end portion 30 b, 32 b ofeach of the first and second driven members 30, 32 has a gear 70, 72,such as, for example, a spur gear, attached thereto in meshingengagement with the gear teeth 68 of the collar 58. In aspects, the spurgears 70, 72 may be operably coupled to the gear teeth 68 of the collar58 via an intermediary gear. In other embodiments, the distal endportion 30 b, 32 b of each of the first and second driven members 30, 32may be operably coupled to the collar 58 via any suitable mechanism,such as, for example, frictional engagement.

Due to the engagement between the first and second driven members 30, 32and the collar 58, a manual rotation of the collar 58 results in arotation of the first and second driven members 30, 32 about theirrespective longitudinal axes. It is contemplated that the collar 58 maybe used in the instance that the instrument drive unit 20 is notattached to the uterine manipulator 10, if power is otherwise notavailable, and/or if additional manual force is desired.

The first and second nuts 48, 50 of the articulation assembly 38 arethreadedly coupled to the threading 53 defined along the respectivefirst and second driven members 30, 32. Each of the first and secondnuts 48, 50 may be rotationally restrained by an internal structure ofthe housing 36 so that rotation of the first and second driven members30, 32 results in only axial motion of the first and second nuts 48, 50along the first and second driven members 30, 32.

The first and second cables 52, 54 of the articulation assembly 38 arerigid and maintain a linear shape during actuation of the articulationassembly 38. In some aspects, the cables 52, 54 may be fabricated from aflexible material. The cables 52, 54 each have a proximal end portion 52a, 54 a disposed within the housing 36, and a distal end portion 52 b,54 b (FIG. 10 ). The proximal end portion 52 a, 54 a of each of thecables 52, 54 is fixed to the respective first and second nuts 48, 50via a pin-slot engagement. In other aspects, the proximal end portion 52a, 54 a of each of the cables 52, 54 may be fixed, either directly orindirectly, to the respective first and second nuts 48, 50 via anysuitable fastening engagement, such as, for example, adhesives, screws,rivets, knots, or the like.

As best shown in FIG. 10 , the distal end portion 52 b of the firstcable 52 is fixed to a first side 42 a of the tip hub 42, and the distalend portion 54 b of the second cable 54 is fixed to a second side 42 bof the tip hub 42. In this way, a translation of the first cable 52 in afirst direction (e.g., a distal direction) coupled with a translation ofthe second cable 54 in a second direction (e.g., a proximal direction),opposite the first direction, causes an articulation of the tip hub 42,along with the tip member 34, relative to the shaft 40. Although shownas pivotable along a single axis, it is contemplated that distal portionof shaft 40 may include articulation links thereby enabling pivoting orarticulation of the tip hub 42 relative to the shaft 40 about multiplepivot axes.

The tip member 34 of the uterine manipulator 10 is attached to the tiphub 42 and has a head portion 76 and an elongate rod 78 extendingdistally from the head portion 76. In aspects, the tip member 34 may bemonolithically formed with the tip hub 42. The head portion 76 may havea distally-facing surface 80 having a frustoconical shape configured toengage the external surface of a cervix. The elongate rod 78 of the tipmember 34 may have an elongated, expandable balloon (not shown) forengaging a cervical canal to aid in repositioning of a uterus. Theballoon may have a supply line (not shown) extending therefromconfigured to be coupled to a source of fluid (e.g., gas or liquid) toselectively expand the balloon. The supply line may be an internallumen, or multiple internal lumens, extending through an interior of theshaft 40. Alternatively, the supply line may be one or more externallumens extending along an outer surface of the shaft 40.

The cervical cup 46 of the uterine manipulator 10 is configured tocapture a cervix therein and is pivotably coupled to the distal endportion 44 of the shaft 40. The head portion 76 of the tip member 34 isreceived in an opening 82 defined in the cervical cup 46, which is sizedto capture the head portion 76 therein, such that the tip member 34 andthe cervical cup 46 articulate together as one unit. The elongate rod 78of the tip member 34 extends distally from the cervical cup 46 and iscentrally disposed therein. The cervical cup 46 may be pivotably coupledto a sleeve 84 that is slidably disposed about and detachably coupled tothe shaft 40.

The sleeve 84 includes a distal portion 84 b and a proximal portion 84 apivotably coupled to the distal portion 84 b. The distal portion 84 b ofthe sleeve 84 is slidable along and relative to the shaft 40 to positionthe cervical cup 46 about the tip member 34 when ready for use. Uponpositioning the distal portion 84 b of the sleeve 84 and the attachedcervical cup 46 in an in-use position (FIG. 9 ), the proximal portion 84a of the sleeve 84 may be pivoted from a first state (FIG. 9 ), in whichthe proximal portion 84 a is disconnected from the shaft 40, to a secondstate (FIG. 6 ), in which the proximal portion 84 a is aligned with thedistal portion 84 b and is connected to the shaft 40. In the secondstate, the sleeve 84 and the cervical cup 46 are axially fixed to theshaft 40. It is contemplated that the proximal portion 84 a of thesleeve 84 may be releasably engaged to the shaft 40 via a friction fitengagement or any suitable fastening engagement.

The sleeve 84 may have a vaginal occluder balloon (not shown) disposedabout the distal portion 84 b thereof. The vaginal occluder balloon isexpandable within the vagina to facilitate securing the uterinemanipulator in a selected position relative to the uterus. The vaginaloccluder balloon may have a supply line (not shown) extending therefromconfigured to be coupled to a source of fluid (e.g., gas or liquid) forselectively expanding the vaginal occluder balloon. The supply line maybe an internal lumen, or multiple internal lumens, extending through aninterior of the shaft 40. Alternatively, the supply line may be one ormore external lumens extending along an outer surface of the shaft 40.

In operation, a hysterectomy or other uterine manipulation procedure maybe performed utilizing the uterine manipulator 10 of the presentdisclosure. During, or in preparation for, the procedure, the uterinemanipulator 10 is either, or both, manually operated by a user and/orcoupled to the robotic arm 2 and an instrument drive unit 20. Uponcoupling the uterine manipulator 10 to the instrument drive unit 20, thedrive members 26, 28 of the instrument drive unit 20 are operablycoupled with the first and second driven members 30, 32 of the uterinemanipulator 10.

To robotically articulate the tip member 34 of the uterine manipulator10, the first and second motors 22, 24 of the instrument drive unit 20are actuated, whereby the first and second drive members 22, 24 rotatein opposite directions to rotate the first and second driven members 30,32 of the uterine manipulator 10 in opposite directions. In someaspects, instead of rotating the first and second driven members 30, 32in opposite directions, the first and second driven members 30, 32 mayhave opposite thread handedness, e.g., the first driven member 30 mayhave a right-handed thread whereas the second driven member 32 may havea left-handed thread.

Since the first and second nuts 48, 50 are threadedly coupled to thefirst and second driven members 30, 32, rotation of the first and seconddriven members 30, 32 drive a translation of the first and second nuts48, 50 along the respective first and second driven members 30, 32 inopposite directions from one another. For example, the first nut 48 maytranslate distally whereas the second nut 50 may translate proximally.As the first nut 48 translates distally, so does the first cable 52, andas the second nut 50 translates proximally, so does the second cable 54.Due to the distal end portion 52 b, 54 b of the first and second cables52, 54 being fixed to opposing sides 42 a, 42 b of the pivot hub 42/tipmember 34, the tip member 34 articulates relative to the distal endportion 44 of the shaft 40. When the tip member 34 is disposed within auterus, articulation of the tip member 34 functions to manipulate theuterus and maintain the uterus in a selected position. Manualarticulation of the tip member 34 of the uterine manipulator 10 may beaccomplished via rotation of rotatable collar 58 in either direction tolikewise drive a translation of the first and second nuts 48, 50 alongthe respective first and second driven members 30, 32 in oppositedirections from one another, as detailed above.

Persons skilled in the art will understand that the devices and methodsspecifically described herein and illustrated in the accompanyingdrawings are non-limiting exemplary embodiments. It is envisioned thatthe elements and features illustrated or described in connection withone exemplary embodiment may be combined with the elements and featuresof another without departing from the scope of the present disclosure.As well, one skilled in the art will appreciate further features andadvantages of the disclosure based on the above-described embodiments.Accordingly, the disclosure is not to be limited by what has beenparticularly shown and described, except as indicated by the appendedclaims.

What is claimed is:
 1. A uterine manipulator comprising: a housingconfigured to be coupled to an instrument drive unit of a roboticsystem; a shaft extending distally from the housing; a tip hub pivotablycoupled to a distal end portion of the shaft; an articulation assemblydisposed within the housing and configured to pivot the tip hub relativeto the shaft, the articulation assembly including a drive cable operablycoupled to the tip hub and being actuatable manually by a user androbotically by the robotic system to pivot the tip hub relative to theshaft; and a handle operably coupled to at least one of the shaft or thehousing, the handle configured to be manually gripped by a user formanual use of the uterine manipulator, wherein the handle is pivotablerelative to the housing or the shaft to pivot the tip hub relative tothe shaft, and wherein the handle defines a window opening forpermitting the articulation assembly to couple to the instrument driveunit of the robotic system when the handle is coupled to the housing. 2.The uterine manipulator according to claim 1, wherein the articulationassembly includes: a first driven member rotationally supported in thehousing and having a proximal end portion configured to be operablycoupled to a first drive member of the instrument drive unit; and afirst nut threadedly coupled to the first driven member, such that thefirst nut translates along the first driven member upon rotation of thefirst driven member, wherein a proximal end portion of the drive cableis operably coupled to the first nut and a distal end portion of thedrive cable is operably coupled to the tip hub, such that the drivecable is configured to longitudinally translate with the first nut andrelative to the first driven member in response to a rotation of thefirst driven member to articulate the tip hub relative to the shaft. 3.The uterine manipulator according to claim 2, wherein the articulationassembly includes: a second driven member rotationally supported in thehousing and having a proximal end portion configured to be operablycoupled to a second drive member of the instrument drive unit; a secondnut threadedly coupled to the second driven member, such that the secondnut translates along the second driven member upon rotation of thesecond driven member; and a second drive cable having a proximal endportion operably coupled to the second nut, and a distal end portion,the distal end portion of the drive cable being coupled to a first sideof the tip hub, and the distal end portion of the second drive cablebeing coupled to a second side of the tip hub.
 4. The uterinemanipulator according to claim 2, further comprising a rotatable collar,wherein the first driven member has a distal end portion operablycoupled to the collar, such that a rotation of the collar rotates thefirst driven member.
 5. The uterine manipulator according to claim 4,wherein the collar has a plurality of gear teeth extending from an innerperiphery thereof, and the distal end portion of the first driven memberhas a gear in meshing engagement with the plurality of gear teeth of thecollar.
 6. The uterine manipulator according to claim 2, wherein thefirst driven member is parallel with and offset from a longitudinal axisdefined by the shaft.
 7. The uterine manipulator according to claim 1,wherein the handle extends outward from a proximal portion of thehousing and is permanently coupled to the housing.
 8. The uterinemanipulator according to claim 1, wherein the handle is removablycouplable to a proximal portion of the housing and includes: a couplingmember for releasably coupling the handle to the housing.
 9. The uterinemanipulator according to claim 1, wherein the handle is operably coupledto the housing via a hinge as is movable between an unfoldedconfiguration, where the handle extends substantially perpendicularrelative to a surface of the housing, and a folded configuration, wherethe handle extends substantially parallel along the surface of thehousing.
 10. The uterine manipulator according to claim 9, wherein thehousing defines a recess configured to receive the handle in the foldedconfiguration.
 11. The uterine manipulator according to claim 1, whereinthe shaft is detachable from the housing and the handle is operablycoupled to the shaft.
 12. The uterine manipulator according to claim 1,wherein at least a distal portion of the shaft is curved.
 13. Theuterine manipulator according to claim 1, wherein the shaft defines aninternal lumen extending along a length of the shaft.
 14. A uterinemanipulator comprising: a housing configured to be coupled to aninstrument drive unit of a robotic system; a shaft extending distallyfrom the housing; a tip hub pivotably coupled to a distal end portion ofthe shaft; an articulation assembly disposed within the housing andconfigured to pivot the tip hub relative to the shaft, the articulationassembly including a drive cable operably coupled to the tip hub andbeing actuatable manually by a user and robotically by the roboticsystem to pivot the tip hub relative to the shaft, wherein thearticulation assembly includes: a first driven member rotationallysupported in the housing and having a proximal end portion configured tobe operably coupled to a first drive member of the instrument driveunit; and a first nut threadedly coupled to the first driven member,such that the first nut translates along the first driven member uponrotation of the first driven member, wherein a proximal end portion ofthe drive cable is operably coupled to the first nut and a distal endportion of the drive cable is operably coupled to the tip hub, such thatthe drive cable is configured to longitudinally translate with the firstnut and relative to the first driven member in response to a rotation ofthe first driven member to articulate the tip hub relative to the shaft;and a handle pivotably coupled to the housing via a hinge and movablebetween an unfolded configuration, where the handle extendssubstantially perpendicular relative to a surface of the housing, and afolded configuration, where the handle extends substantially parallelalong the surface of the housing, the handle configured to be manuallygripped by a user for manual use of the uterine manipulator, wherein thehandle is pivotable relative to the housing to pivot the tip hubrelative to the shaft.
 15. The uterine manipulator according to claim14, further comprising a rotatable collar operably coupled to thearticulation assembly and configured to be manually rotated to pivot thetip hub relative to the shaft.
 16. The uterine manipulator according toclaim 14, wherein the housing defines a recess and the handle isconfigured to be positioned within the recess when in the foldedconfiguration.
 17. The uterine manipulator according to claim 14,wherein the articulation assembly includes: a second driven memberrotationally supported in the housing and having a proximal end portionconfigured to be operably coupled to a second drive member of theinstrument drive unit; a second nut threadedly coupled to the seconddriven member, such that the second nut translates along the seconddriven member upon rotation of the second driven member; and a seconddrive cable having a proximal end portion operably coupled to the secondnut, and a distal end portion, the distal end portion of the drive cablebeing coupled to a first side of the tip hub, and the distal end portionof the second drive cable being coupled to a second side of the tip hub.18. A uterine manipulator comprising: a housing configured to be coupledto an instrument drive unit of a robotic system; a shaft extendingdistally from the housing; a tip hub pivotably coupled to a distal endportion of the shaft; an articulation assembly disposed within thehousing and configured to pivot the tip hub relative to the shaft, thearticulation assembly including a drive cable operably coupled to thetip hub and being actuatable manually by a user and robotically by therobotic system to pivot the tip hub relative to the shaft; and a handleremovably coupled to the housing, the handle configured to be manuallygripped by a user for manual use of the uterine manipulator when thehandle is coupled to the housing, wherein the handle is pivotablerelative to the housing to pivot the tip hub relative to the shaft, andwherein the handle defines a window opening for permitting thearticulation assembly to couple to the instrument drive unit of therobotic system when the handle is coupled to the housing.
 19. Theuterine manipulator according to claim 18, further comprising arotatable collar operably coupled to the articulation assembly andconfigured to be manually rotated to pivot the tip hub relative to theshaft.